Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers

Feasibility of Remote Wound Care: Implementing a Patient-Centered Remote Wound Monitoring Solution Using a Smartphone Application

This research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot; Diabetes Complications; Diabetic Foot Ulcer; Wound; Foot; Wound Heal; Wound Leg
• Intervention / Treatment: Other: Remote wound monitoring technology

Detailed Description

The purpose of this research is to determine if a smartphone mobile application, also referred to as a mobile app or simply an app, designed to capture wound measurements and analyze wound tissue distribution in real-time, can be a practical patient-centered solution for regular wound management and assessment. The app will be compared to traditional in-person wound monitoring. One of the major limitations of most literature describing remote monitoring technologies is the lack of a control group. By randomizing half of the enrolled patients to remote monitoring via standard of care, the investigators will be able to compare patient and provider satisfaction with remote vs. in-person monitoring, as well as the wound healing outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin Hicks, MD; Phone Number: 410-955-5165; Email: chicks11@jhmi.edu
• Study Contact Backup: Name: Sherry Leung; Phone Number: 410-955-7518; Email: sleung7@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Caitlin Hicks, MD; Phone Number: 410-955-5165

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged ≥ 18 years old
• In treatment for lower extremity wound related to diabetic foot ulcer
• Able and willing to use a smartphone to assess the wound for the duration of the study
• English language proficiency

Exclusion Criteria:

• Patients with less than 1 dressing change per week
• Patients with wound size that cannot be covered with a single app scan (out of boundary conditions include wounds that wrap around patient's entire leg)
• Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed.
Experimental: Remote wound monitoring technology; Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12).	Other: Remote wound monitoring technology; Healthy.io developed a professional-user wound management system that captures wound measurements and analyzes tissue distribution in real time through a smartphone application. Clinical oversight of the healing status of the wound via remote imaging and expert review allows for real time intervention when stagnation or worsening of a wound is detected. Patients with wounds on their legs will receive access to Healthy.io's mobile app and will be able to perform self-scans of their wound which will be automatically sent to the medical professionals, thus allowing them to assess the wound remotely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who successfully complete a weekly wound scan	Overall weekly scan rate	12 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Caitlin Hicks, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Wounds and Injuries; Diabetic Foot; Foot Ulcer; Diabetes Complications
• Other Study ID Numbers: IRB00292929; R03DK133557 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No